DIHYDROERGOTAMINE MESYLATE Recall D-1011-2022
Description: Dihydroergotamine Mesylate, Injection, USP, 1mg/mL, packaged in box of 5 x 1 mL ampules, Rx only, Manufactured for: Perrigo, Minneapolis, MN, NDC 0574-0850-10
DIHYDROERGOTAMINE MESYLATE Recall D-1011-2022 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | D-1011-2022 |
Event ID | 89646 |
Brand | DIHYDROERGOTAMINE MESYLATE |
Generic Name | DIHYDROERGOTAMINE MESYLATE |
Manufacturer | DIHYDROERGOTAMINE MESYLATE |
Original Package? | 1 |
Active Substance | DIHYDROERGOTAMINE MESYLATE |
Drug Route | INTRAMUSCULAR |
Distribution | USA nationwide. |
Quantity | 1 carton |
Recall Reason | cGMP deviations: Temperature abuse |
Drug Classification | Class II |
Drug Code Info | 20220615 |
Product NDC | 0574-0850 |
Recall Initiation Date | 20220413 |
Report Date | 20220615 |
Classification Date | 20220609 |
Address | 9954 Maryland DriveDeep Run Iii Ste. 4000 Richmond, VA 23233 United States |
Recalling Firm | Mckesson Medical-Surgical Inc. Corporate Office |
Initial Notification | Letter |
Unique Ingredient Identifier | 81AXN7R2QT |
Drug Application Number | ANDA040475 |
Structured Product Labeling (SPL ID) | bddefdbb-8713-456f-993f-458ddd94803f |
Structured Product Labeling (SPL Set ID) | 111f628a-7e1e-4d47-8ac1-f898cbfc9b74 |
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